- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03195244
Aquatic Therapy and Autism Spectrum Disorders (AT&ASD)
April 20, 2022 updated by: Sloan W. Rush, MD
To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Amarillo, Texas, United States, 79106
- Turn Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 17 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Eligibility criteria:
- DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD
- Treatment naïve to prior aquatic therapy
Exclusion criteria:
- Not willing to undergo an investigational treatment
- Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
- Known allergies to pool chemicals
- Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Observation
|
|
ACTIVE_COMPARATOR: One-on-one Aquatic Therapy
|
Swim Whisperer's Aquatic Therapy Sessions
|
EXPERIMENTAL: Group Aquatic Therapy
|
Swim Whisperer's Aquatic Therapy Sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PedsQL Score
Time Frame: Baseline and 10 weeks after intervention
|
Survey
|
Baseline and 10 weeks after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 12, 2017
Primary Completion (ACTUAL)
April 12, 2022
Study Completion (ACTUAL)
April 12, 2022
Study Registration Dates
First Submitted
June 12, 2017
First Submitted That Met QC Criteria
June 20, 2017
First Posted (ACTUAL)
June 22, 2017
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AT&ASD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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